Generic multi-step therapeutic treatment protocol

ABSTRACT

A generic treatment protocol is disclosed for therapeutically treating a patient via an implantable treatment device. Treatment steps can be defined to start and end at absolute times, or can be programmed via telemetry to start a certain amount of time after termination of a previously executed treatment step. Treatment steps have a treatment rate or dose attribute and a duration attribute. Treatment steps may optionally enable patient-activated bolus overlays. Patient-activated rate or dosage adjustments can also optionally be enabled. Repeated-execution treatment-step groups are also provided. Such treatment-step groups can have start and end times, a group duration, and a group total dose, each defined in a manner similar to that for a treatment step. Treatment-step groups include a repetition count, which could be set to a value that causes the group to repeat forever. Single execution treatment steps can, accordingly, be programmed to execute before and/or after a repeated-execution treatment-step group.

This application is a divisional of prior application Ser. No.09/302,613, filed Apr. 30, 1999, now U.S. Pat. No. 6,579,280.

FIELD OF THE INVENTION

This invention relates to generic building blocks for specifying variousmodes of treating a patient via drug infusion or electrical nervestimulation using a generic multi-step treatment protocol includingsingle-execution treatment steps and repeated-execution treatment-stepgroups.

BACKGROUND OF THE INVENTION

Devices and techniques for treating neurological disorders by druginfusion and by electrical stimulation of a person's central nervoussystem are well known in the prior art. For instance, U.S. Pat. No.5,713,922 to King, 5,782,798 to Rise, and U.S. Pat. No. 5,814,014 toElsberry et al., each assigned to Medtronic, Inc. of Minneapolis, Minn.,disclose such devices and techniques and are hereby incorporated byreference.

Such treatment devices and techniques often employ drug-infusion pumpsand/or electrical pulse generators that are implanted within a patient'sbody. Accordingly, available memory for storing the parameters, such astreatment dose, duration, and timing, of various treatment protocols isseverely limited. As a result, known implantable treatment devices arecapable of storing a treatment protocol via telemetry that implementsonly a single treatment mode, such as single bolus, simple continuous,periodic bolus, or complex continuous treatment protocols. Single bolusrefers to a non-recurring, finite treatment period. Simple continuous isa continuous treatment at a fixed treatment level. Periodic bolus refersto a single periodically recurring finite treatment period. Complexcontinuous refers to a plurality of treatment periods that periodicallyrepeat themselves.

FIG. 2 depicts a prior art manner of specifying a complex continuoustreatment protocol. The vertical axis represents the treatment rate. Thehorizontal axis represents elapsed time from the treatment protocolhaving been downlinked to the treatment device. In FIG. 2, the locationof the vertical axis along the horizontal axis represents the time atwhich the treatment protocol was downloaded to the treatment device, asdepicted at 100. For each example given in this document, the time atwhich the treatment prescription was downlinked to the treatment devicewill be assumed to be 3:00 PM, local time. In FIG. 2, a complexcontinuous treatment protocol is depicted in which a background rate of20 microliters/hour is infused, as depicted at 102-1 through 102-8(collectively 102). Note that, while the examples refer to infusionprotocols, they are equally applicable to stimulation protocols.Background rate 102 is in effect when no treatment step is beingperformed.

The complex continuous treatment protocol depicted in FIG. 2 has theadditional following attributes: the treatment cycle time is 24 hours;between 6:00 AM and 8:00 AM, 600 microliters is infused; between 11:00AM and 1:00 PM, 200 microliters is infused; and between 9:00 PM and11:00 PM, 500 microliters is infused.

In order to program such a treatment protocol using known prior artmethods, treatment step 104-1, which corresponds to the 500 microlitertreatment step from 9–11 PM, is programmed to start after a delay of 6hours from the time the protocol is downlinked to the treatment device,namely, 3:00 PM. The treatment rate is determined by dividing the doseby the treatment-step duration, in this case 500 microliters divided by2 hours, which is 250 microliters/hour. Accordingly, treatment step104-1 would be programmed to include a delay from downlinking of 6hours, during which the background treatment rate would be in effect, asdepicted by 102-1. Treatment step 104-1 would also be programmed toprovide treatment at 250 microliters/hour for 2 hours. Similarly,treatment step 106-1 would be programmed to include a delay from thecompletion of treatment step 104-1 of 7 hours, during which backgroundtreatment 102-2 would be in effect, and treatment at 300microliters/hour for 2 hours. Treatment step 108-1 would be programmedto include a delay from the completion of treatment step 106-1 of 3hours, during which background treatment 102-3 would be in effect, andtreatment at 100 microliters/hour for 2 hours.

Following the completion of treatment step 108-1, background rate 102-4would be in effect for the remaining 2 hours of the 24-hour treatmentcycle.

Then, the 24-hour cycle would repeat itself in perpetuity or until a newtreatment protocol is downlinked to the treatment device. Accordingly,background rates 102-5 through 102-8 of the second 24-hour treatmentcycle shown in FIG. 2 correspond to background rates 102-1 through102-4, respectively, of the first 24-hour treatment cycle shown in FIG.2. Similarly, treatment steps 104-2, 106-2, and 108-2 of the second24-hour treatment cycle shown in FIG. 2 correspond to treatment steps104-1, 106-1, and 108-1, respectively, of the first 24-hour treatmentcycle shown in FIG. 2.

Such known methods of specifying treatment protocols undesirably requirethat each time a change from one infusion mode, such as single bolus,simple continuous, periodic bolus, or complex continuous, to anotherinfusion mode is desired, the new treatment protocol must be downlinkedto the treatment device. In other words, known implantable treatmentdevices are incapable of storing multiple treatment-mode protocols.Patients and physician-programmers of such treatment devices aretherefore severely inconvenienced by having to re-program such treatmentdevices each time an infusion mode change is made.

BRIEF SUMMARY OF THE INVENTION

It is therefore an object of this invention to overcome the shortcomingsof the prior art by providing a generic treatment protocol for treatinga patient via an implantable treatment device. The generic treatmentprotocol of this invention provides significantly improved versatilityin implementing known treatment protocols, without the inconvenience ofre-programming upon transitions between different treatment modes thatis required when programming treatment protocols using prior artmethods. In addition, the generic manner in which various treatmentprotocols can be specified using this invention also providessignificant advantages for implementing newly created treatmentprotocols and for altering treatment protocols based on criteria such apatient travel between different time zones.

In one embodiment, the protocol includes a user-selectable number of oneor more treatment steps, each having a corresponding duration, and oneor more treatment-step groups, each having one or more treatment steps,a user-selectable treatment-step-group repetition count, and auser-selectable treatment-step-group duration. Additional aspects of thegeneric treatment protocol include: the capability of programming atleast one of the treatment-steps to repeat forever; a series ofsingle-execution treatment steps optionally executed initially uponprogramming the implantable treatment device; at least one of thetreatment-step groups including: an absolute start time and an absoluteend time, a start delay relative to completion of another treatmentstep, a user-selectable treatment rate, a user-selectable treatmentdose, a patient-activated bolus, and/or a patient-activated rateadjustment.

In another embodiment of this invention, a therapeutic treatment deviceadapted to be implanted within a patient's body has a computer-readablemedium that stores computer-executable instructions for providing auser-selectable number of one or more treatment steps for treating apatient using an implantable treatment device. Each of the treatmentsteps has a corresponding user-selectable treatment-step duration. Inaddition, the treatment-device computer-readable medium storescomputer-executable instructions for providing one or moretreatment-step groups. Each of the treatment-step groups includes: auser-selectable number of treatment steps; a user-selectabletreatment-step-group repetition count; and a user-selectabletreatment-step-group duration. The treatment-device computer-readablemedium also contains further computer-executable instructions forperforming steps analogous to the additional aspects of the generictreatment protocol set forth in the immediately preceding paragraph.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a patient with a treatment deviceimplanted within the patient's body.

FIG. 2 depicts a complex continuous mode treatment protocol specifiedusing prior art methods.

FIG. 3 depicts the same complex continuous mode treatment protocol as inFIG. 2, specified using the generic treatment protocol of thisinvention.

FIG. 4 depicts a complex continuous mode treatment protocol and a bolus.

FIG. 5 depicts the same complex continuous mode treatment protocol as inFIG. 4, a patient-activated rate increase, and two patient-activatedboluses.

FIG. 6 depicts two different ways of transitioning from single-executiontreatment steps to a repeated-execution treatment-step group.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a schematic view of a patient 10 having treatment device 14implanted within the patient's body. Implantable treatment device 14 isprogrammable through a telemetry link from programmer 20, which iscoupled via a conductor 22 to a radio frequency antenna 24. Treatmentdevice 14 could be, but is not limited to being, a pump for infusingmedicaments into a patient's body or an electrical nerve stimulator forstimulating a patient's nervous system.

The fundamental building block for specifying various treatmentprotocols according to this invention is referred to as a treatmentstep. Treatment steps may be specified to start after a predetermineddelay relative to downlinking of the treatment protocol to the implanteddevice or relative to completion of the preceding treatment step or anyother suitable point in time. In the alternative, a treatment step mayhave a specified absolute start time and/or date. A treatment stepaccording to this invention will include a treatment rate or dose and atreatment duration. A treatment step could also specify whether or not apatient-activated bolus may overlay the treatment step and whether, andif so, how much, of a patient-activated rate adjustment is allowedduring the treatment step.

Treatment steps according to this invention are typically specified asexecuting one time. By grouping one or more treatment steps into atreatment-step group, the group of one or more treatment steps can bespecified to repeat according to the treatment-step groupspecifications. Treatment-step groups according to this inventioninclude a start time and/or date, which can be specified as either adelay or as an absolute time and/or date, as is the case for treatmentsteps. Treatment-step groups may include the number of treatment stepsin the group. Treatment-step groups can include a background rate, whichspecifies the treatment rate when no treatment step is in effect. Arepetition count is also included. The repetition count is capable ofindicating that the group should repeat forever. Treatment-step groupsalso have a duration or period. A treatment-step group could have amaximum dosage associated with the group.

In addition to treatment steps and treatment step groups, boluses couldalso be defined separately to include a start delay or start time and/ordate, a treatment rate or dose, a treatment duration, and whether thebolus is low-priority patient-activated, or high-priorityphysician-activated. High priority boluses could always take precedenceover treatment steps, while patient-activated boluses could takeprecedence only over treatment steps that specifically allow themselvesto be overlaid by low-priority boluses.

FIG. 3 depicts the complex continuous mode treatment protocol depictedin FIG. 2, but programmed or specified using the generic treatmentprotocol of this invention. The prescription parameters are the same,namely, the treatment cycle time is 24 hours; between 6:00 AM and 8:00AM, 600 microliters is infused; between 11:00 AM and 1:00 PM, 200microliters is infused; and between 9:00 PM and 11:00 PM, 500microliters is infused. In addition, the complex continuous modetreatment protocol is downlinked to the treatment device at 3:00 PM, asdepicted by dashed line 200-1. The treatment device automaticallydetermines what treatment step or background rate should be executing atdownlink time 200-1. Background rates 102-1 through 102-6 are the sameas those depicted in FIG. 2 with the same reference numbers. However,the delays between treatment steps, such as treatment steps 104-1,106-1, 108-1, and 104-2, may, but need not be specified. The generictreatment protocol of this invention provides backward compatibility sothat physician programmers familiar with existing treatment protocolprogramming methods will be able to use this invention without learninganything new, if a physician programmer so desires. Nevertheless,treatment steps can be programmed using this invention by specifyingtreatment start time, a treatment end time, and a treatment rate or atreatment dose. Accordingly, instead of programming treatment step 104-1as described above, namely, as a delay of 6 hours from the time theprotocol is downlinked to the treatment device and as providingtreatment at 250 microliters/hour for 2 hours, treatment step 104-1could be programmed to provide 500 microliters between a treatment-stepstart time of 9:00 PM and a treatment-step end time of 11:00 PM.Treatment steps can also be specified as either allowing or not allowinga patient activated bolus and/or a patient-activated rate or doseadjustment. The physician-programmer may be provided with the option ofdisabling such patient-activated boluses and/or rate adjustments. Aspecified background rate can optionally be in effect for any period forwhich no treatment step is programmed.

In addition to programming specific treatment steps, treatment-stepgroups can be specified. For instance, the treatment steps 104-1, 106-1,and 108-1 could be defined as a treatment-step group including thesethree treatment steps. Such a treatment-step group could also include arepetition count specifying the number of times the treatment-step groupshould be executed. The treatment-step group could also be programmed torepeat forever. The duration of the treatment-step group is alsoprogrammable/user-selectable, which is advantageous for certaintreatments having a treatment cycle time other than 24 hours, such ascertain types of chemotherapy. The treatment-step group also may includea maximum incremental dosage for each iteration of a treatment-stepgroup.

FIG. 4 depicts an exemplary programmed treatment protocol including abolus followed by a complex continuous mode treatment protocol accordingto the following parameters: background rate: 60 microliters/hour; groupduration: 24 hours; 6–8 AM: 600 microliters; 11 AM–1 PM: 250microliters; and 9–11 PM: 400 microliters. Bolus 302 of FIG. 4 isdepicted as having been programmed according to the followingparameters: 12–2 PM, 0 microliters; 2–4 PM, 500 microliters/hour; and4–8 PM, 0 microliters/hour. The background rate of 60 microliters/houris in effect as depicted at 300-1. The treatment device is programmedoff, which overrides the background rate, before and after the bolus302. The periods during which the treatment device is off are depictedas 304-1 and 304-2, respectively.

FIG. 5 depicts a patient rate adjustment 400, a patient-activated bolus402, and the interaction between a patient-activated bolus 404 thatpartially overlaps, and is locked-out by, treatment step 406, which hasbeen programmed to disable patient-activated boluses. The complexcontinuous treatment mode prescription depicted in FIG. 5 has the sameattributes as the complex continuous treatment prescription shown inFIG. 4, namely, background rate: 60 microliters/hour; group duration: 24hours; 6–8 AM: 600 microliters; 11 AM–1 PM: 250 microliters; and 9–11PM: 400 microliters. In addition, the 6–8 AM treatment step alsospecifies that patient boluses are disabled during that treatment step.Patient-activated rate increase 400 is depicted as having beenprogrammed as a rate increase of 60 microliters per hour from 4–9 PMover background rate 300. Patient bolus 402 is depicted as having beenprogrammed as 300 microliters per hour from 12–2 AM. Although a patientbolus is attempted from 5–7 AM at 300 microliters per hour, only theportion of the patient bolus from 5–6 AM will actually be administeredbecause from 6–7 AM, patient boluses have been specifically disabledduring programming of treatment step 406. Alternatively, a low-prioritypatient-activated bolus could be disabled in its entirety if any portionof the patient-activated bolus comes within a pre-determined time windoweither before or after a treatment step that disables patient-activatedboluses. In addition to patient-activated low priority boluses,physician-programmer high priority boluses may also be specified. Highpriority boluses are always executed regardless of whether a particulartreatment step has enabled patient-activated boluses. As used herein,the term user refers to a physician who programs the treatment device,as opposed to a patient within whom the treatment device is implanted.

FIG. 6 depicts a set of single execution treatment steps, spanned bydouble-headed arrow 500, that can optionally be executed before repeatedexecution of a treatment-step group, two of which are spanned bydouble-headed arrows 502 and 504. Double-headed and dashed arrow 506represents the time at which the single execution treatment steps 500terminate. Repeated-execution of treatment-step group 502 is depicted asstarting upon termination of single execution treatment steps 500. Thisis a specific example of generically starting execution of arepeated-execution treatment-step group after a predetermined delayelapses relative to termination of single execution treatment steps 500.The predetermined delay between termination of single executiontreatment steps 500 and repeated-execution treatment-step group 502happens to be 0 seconds. As will be apparent, other suitable delayscould also be used, as desired.

Repeated-execution treatment-step group 504 differs fromrepeated-execution treatment-step group 502 in the manner in which itbegins executing upon termination of single-execution treatment steps500. Repeated-execution treatment-step group 504 begins execution, notnecessarily at the beginning of group 504, but at the point in time ofgroup 504 that corresponds to termination of single execution steps 500.In other words, execution of repeated-execution treatment-step group 504begins, or is picked-up, “in-progress” upon completion of singleexecution steps 500, as depicted at 506 in FIG. 6. Completion of eachiteration of treatment-step group 504 is depicted at 512. Uponcompletion of the first iteration of repeated-execution treatment-stepgroup 504, each following iteration of treatment-step group 504 startsat the beginning of group 504, which beginning is depicted at 514.

Following repeated execution treatment step groups 502 and 504 aresingle-execution steps 508 and 510, respectively. Single execution steps508 and/or 510 may optionally be executed following a finite number ofrepetitions of repeated-execution treatment-step groups 502 and/or 504,respectively.

According to an aspect of this invention, the timing of a particulartreatment protocol can be altered according to time zone changes. Forinstance, if a patient is planning to travel from the United States toEurope for a two-week vacation, the timing of treatment steps and/ortreatment-step groups can be programmed to automatically adjust for thetime zone change from the United States to Europe and to re-adjust thetiming upon the expected return to the United States.

1. A computer-readable medium containing computer-executableinstructions that cause a human-implantable therapeutic treatment deviceto perform a specific therapeutic treatment protocol by performing stepscomprising: performing at least one treatment step that is defined, atleast in part, by generic treatment parameters including a treatmentrate or dose and a treatment duration, which have been downlinked to thetreatment device; performing at least one treatment-step group a numberof times that is specified by a treatment-step-group repetition countthat has been downlinked to the treatment device; and administering atleast one activated bolus in accordance with downlinked generictreatment parameters including: a start delay or start time, a treatmentrate or dose, and a treatment duration.
 2. The computer-readable mediumof claim 1, wherein the at least one treatment step starts executingafter a programmed delay relative to when the generic treatment protocolparameters are downlinked to the implantable device.
 3. Thecomputer-readable medium of claim 1, wherein the at least one treatmentstep is programmed to start executing after a predetermined amount oftime elapses following completion of a preceding treatment step.
 4. Thecomputer-readable medium of claim 1, wherein the at least one treatmentstep starts executing at a programmed absolute start time.
 5. Thecomputer-readable medium of claim 1, comprising furthercomputer-executable instructions for performing a patient-activatedbolus while performing the at least one treatment step.
 6. Thecomputer-readable medium of claim 5, comprising furthercomputer-executable instructions for disallowing an attemptedpatient-activated rate adjustment that would exceed a programmed maximumrate adjustment for the at least one treatment step.
 7. Thecomputer-readable medium of claim 1, wherein the at least onetreatment-step group starts and ends in accordance with an absolutestart time and an absolute end time, respectively.
 8. Thecomputer-readable medium of claim 1, wherein the at least onetreatment-step group starts in accordance with a programmed delayrelative to completion of an earlier executed treatment step.
 9. Thecomputer-readable medium of claim 1, wherein the at least one treatmentstep group includes providing treatment at a background rate when notreatment step is actively providing treatment.
 10. Thecomputer-readable medium of claim 1, wherein a maximum amount oftreatment administered by the at least one treatment-step group islimited by a programmed maximum dosage.
 11. The computer-readable mediumof claim 1, wherein the treatment-step-group repetition count specifiesthat the at least one treatment-step group should repeat forever. 12.The computer-readable medium of claim 1, wherein the bolus includes aprogrammed priority that specifies that the bolus has a priorityselected from the group consisting of: a low-priority patient-activatedbolus that takes precedence over treatment steps that specifically allowthemselves to be overlaid by low-priority boluses, and a high-priorityphysician-activated bolus that takes precedence over treatment steps.13. A system for causing a human-implantable therapeutic treatmentdevice to perform a specific therapeutic treatment protocol, the systemcomprising: means for performing at least one treatment step that isdefined, at least in part, by generic treatment parameters including atreatment rate or dose and a treatment duration, which have beendownlinked to the treatment device; means for performing at least onetreatment-step group a number of times that is specified by atreatment-step-group repetition count that has been downlinked to thetreatment device; and means for administering at least one activatedbolus in accordance with downlinked generic treatment parametersincluding: a start delay or start time, a treatment rate or dose, and atreatment duration.
 14. The system of claim 13, wherein the at least onetreatment step starts executing after a programmed delay relative towhen the generic treatment protocol parameters are downlinked to theimplantable device.
 15. The system of claim 13, wherein the at least onetreatment step is programmed to start executing after a predeterminedamount of time elapses following completion of a preceding treatmentstep.
 16. The system of claim 13, wherein the at least one treatmentstep starts executing at a programmed absolute start time.
 17. Thesystem of claim 13, further comprising: means for performing apatient-activated bolus while performing the at least one treatmentstep.
 18. The system of claim 13, further comprising: disallowing anattempted patient-activated rate adjustment that would exceed aprogrammed maximum rate adjustment for the at least one treatment step.19. The system of claim 13, wherein the at least one treatment-stepgroup starts and ends in accordance with an absolute start time and anabsolute end time, respectively.
 20. The system of claim 13, wherein theat least one treatment-step group starts in accordance with a programmeddelay relative to completion of an earlier executed treatment step. 21.The system of claim 13, wherein the at least one treatment step groupincludes means for providing treatment at a background treatment whileno treatment step is actively providing treatment.
 22. The system ofclaim 13, wherein a maximum amount of treatment administered by the atleast one treatment-step group is limited by a programmed maximumdosage.
 23. The system of claim 13, wherein the treatment-step-grouprepetition count specifies that the at least one treatment-step groupshould repeat forever.
 24. The system of claim 13, wherein the bolusincludes a programmed priority that specifies that the bolus has apriority selected from the group consisting of: a low-prioritypatient-activated bolus that takes precedence over treatment steps thatspecifically allow themselves to be overlaid by low-priority boluses,and a high-priority physician-activated bolus that takes precedence overtreatment steps.